Status:
COMPLETED
Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study will determine the efficacy of a medication switch to Aripiprazole for the treatment of schizophrenia or schizoaffective disorder in patients with moderate to high symptoms of social anxiet...
Detailed Description
Although research has shown that social anxiety is very common among patients suffering from schizophrenia or schizoaffective disorder, it is rarely diagnosed and treated in this patient population. T...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients meeting DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder.
- Patients presenting with comorbid social anxiety symptoms of moderate to high severity are eligible for participation in the study. Only patients with LSAS scores above 30\* qualify for the study.
- Age 18-65
- Gender: males or females
- Females: non-pregnant, not of child-bearing potential; if of child-bearing age must be on contraceptive such as pill or shot (condom alone not sufficient)
- Good general health
- Exclusion Criteria:
- Patient does not meet DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder
- Patient carries a diagnosis of dementia, degenerative CNS disorders, mental retardation, substance abuse or dependence other than nicotine dependence or alcohol abuse will be excluded from the study.
- Patients with acute medical conditions are not eligible.
- Patients allergic or otherwise intolerant or non-responsive to Aripiprazole
- Patient with history of suicidal, homicidal or assaultive plans or attempts in the past 6 months.
- Clinically significant EKG or lab abnormalities
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00177008
Start Date
March 1 2004
End Date
January 1 2007
Last Update
January 29 2007
Active Locations (1)
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1
Robert Wood Johnson Medical School - Psychiatry Dept.
Piscataway, New Jersey, United States, 08854